Tag Archives: Clinical trial

Since returning from my medical and holiday travels a few people have inquired, “So now, what is your status?” Ah, what a relevant question. Despite blogging, or maybe because of blogging, readers have been stuck on the same fast moving rollercoaster of highs, lows and plateaus as the patient, me. As we close out 2013, let me do my own little summary.

I close the year with apparent stability in my cancer. Stable is a very good word for a metastatic cancer patient living in treatment. Stable is my best bridge available to the next test results, especially given that I currently have some inconsistent results. Stable is a concept I intend to enjoy until the next round of internal tests in mid March.

Stability was my dream for 2012. That was a truly rocky year of new treatment regimes being met by new cancer growth, not a reality that can be sustained. A hard fought for surgery yielded better then anticipated results (bye-bye 10 cm of cancer) followed by a low dose chemo regime that finally reduced my remaining cancer bringing me to a start of 2013 where stability seemed possible.

2013 was a fairly easy year. I experienced the expertise and comforts of OHSU, enjoyed the easiest chemo protocol yet as I chipped away at the criteria to allow entry into the UPenn immunology trial. In early April a friend met me in Philadelphia for an intake visit that lead to my enrollment in the trial with treatment starting the first week of June 2013. Testing in January, May and September of 2013 was all relatively calm given the comforting lab results I was getting every three weeks. I was stable.

This fall, of course, began a rise in lab results and the pronouncement of new cancer and ascites (fluid in the pelvis) in the initial December scan, fast rectified by further scans and a lovely bit of holiday cheer. Who knows what is real?

I end 2013 ever aware that I reside on a cliff’s edge. I place my foot down with family and friends cheering me on and a stellar medical team leading the process. But it is my foot touching down on whatever loose rocks or solid earth is destined to be next. I could plummet or I could close out 2014 boringly stable. We all find out together.

A Happy New Year good luck marzipan pig!

I am proud I met my own goal to make 2013 a year I regained some sort of larger life. I focused on my Open Society Fellowship production of a how-to manual on organizing – the final completion date is this June. I was interviewed for a national magazine article covering creative approaches to community organizing. And, I started a blog called Livingly Dying that has had 17,827 visitors from 82 countries. I plan to continue these projects, tucked in meaningfully between the more mundane full time job of staying alive.

May my 2014 be a very, very long and stable year and may yours be whatever you seek.

Dogs, and the companionship they offer, have been a big part of my life. As a child I calculated for years before talking my parents into a family dog. The humane society was where I found my pups during my adult years. First Sahm, then Boscoe then Tony. I wrote them into job contracts and rental agreements so that the dogs went where I went, they were part of the Marcy package. When diagnosed with terminal cancer, my long time dog pal of 16 years was on his last legs. He was increasingly deaf and blind and the drama of that year was hard for his deteriorating systems. He hung on and on but died the summer after my diagnosis. I was dogless.

My husband, taking seriously the needs of caretaking me, seeks anything that makes our lives simpler. He liked having no dog. The next summer a lovely cat with enormous personality moved into our backyard. We co-existed well. The cat clearly was feeding herself and content so we just enjoyed the daily visits. When the cold weather set in we finally bought cat food, kitty litter and allowed the cat to continue her co-housing. Mike was thrilled to say, “See, you have an animal.” I responded with, “Yes, a cat.” We both loved the cat and the cat did her best to act the part of a dog, following me from room to room, inside or out, and being a companion. But she was not a dog.

a cat, not a dog

As I began the arduous treks to Philadelphia for treatment this past Spring, entering the Hail Mary Pass of an immunology clinical trial, I felt hopeful and a bit entitled. Surely for all this effort I was earning a chance to reclaim parts of my life. Maybe I couldn’t go back to our home in the woods or working fulltime plus or having long hair but wasn’t this effort worthy of some chit? Wasn’t I now eligible to have a dog in my life? My husband only groaned in response to the rhetorical question. So I plotted in my head leaving occasional breadcrumbs about dog rescues for my husband to acclimate to.

In October, I allowed myself to start looking at photos of dogs needing homes and found an incredibly developed subculture of foster homes and transit routes that brought dogs from high kill shelters in California to Oregon for adoption. Foster homes take in these dogs as the frontline placements to detangle their hair, heal their bodies and secure wounded personas, working miracles within the first week but not without a few reduced sleep nights and much cleaning up of toileting errors. I was privileged to meet a few of these moms as I explored adoption. I stay impressed!

Sawyer was on a larger list of cute possibilities that I wanted to check out. He was actually a bit lower on the list as he looked too much like my last dog but I was learning that the all volunteer infrastructure of this dog rescue world meant that there were a lot of unanswered inquiries and false leads. Sawyer’s foster mom got back to me right away and made checking him out so easy. Plus, she provided guidance, wasn’t scared of my health status and agreed to assist in the transition by taking Sawyer back in during my first travels post adoption. It was perfect. And then there was the fact that Sawyer was pretty darn cute. And so I have a dog in my life again, complicating it hourly (no, that’s my shoe; sure, let’s take another walk; sorry, now we sleep) in a way that reassures me I am going to live while I am alive.

October’s trek to Philly was hard, as I feared it might be. My initial treatment in this trial back in early June 2013 had been my most challenging and now I was returning after a 55-day break. My body might just resist fresh toxins being introduced with a loud “Hell No!”

I am now in the maintenance phase. I get the same chemo cocktail, at the same dose followed a day later by the same vaccines but now on a four-week schedule versus every three weeks. This sequence happens for three months and then I get tested to ensure there is no disease progression requiring redirection into Phase Two. I hope to do this maintenance phase for at least the nine months for which we have the needed material (my tumor to mix with my dendritic cells). But I also hope the next eight months are easier!

My flights presented some sleep challenges – I arrived at 2 a.m. I awoke again at 7 a.m., very little sleep for this delicate unit. The chemo infusion was full of delays. I returned back to my borrowed condo, crawling into bed at 7 p.m. feeling tired and off. I awoke at midnight to blinding head pain, stumbled to the bathroom and preceded to vomit for the next twelve relentless hours.

The Philadelphia Chamber of Commerce, no doubt, was glad when I finally left town. My walk through downtown for the next day’s treatment included stops for further retching. I like to imagine I cast an elegant figure in my red boots, stylish skirt, tucked behind a well-placed Canada Dry delivery truck, sitting on a planter wall, leaning over as if fascinated by some plant discovery quietly voiding my quite empty stomach. I didn’t linger to ask. Once semi-stable, I continued towards my final treatments of this visit.

The vaccines were a piece of cake, thank you. I felt too lousy to exert extra energy to tense up in anticipation of the needle’s journey. When I was officially done, the team decided to infuse me with saline to replenish my fluids making the long flights home less burdensome to my depleted system. Since I was all about sitting anywhere, another shift in a chemo lounge chair seemed most divine.

Trek number ten ended with me home in my own yummy bed by the early hours of the next day. It was all just fine. But no photos or extras for this post.

It seems that 90% of our US government is shut down and 90% of my cancer responded to this new clinical trial. I have more appreciation of my 90% reduction than that of the government. In the government shutdown there are, of course, many innocent and less thought about stories. We might celebrate if 90% of congress was shut down – but no, they continue to create silly chaos and get their paychecks as well; they just shut down 90% of the services to taxpayers.

While congress continues to ‘function’, “…Nearly three-quarters of NIH’s staff are now off the job as a result of the U.S. government shutdown that began on 1 October. It has also stopped processing grant applications and accepting new patients at its clinical research center in Bethesda, Maryland, just outside of Washington, D.C.” Real people count on the National Institute of Health on a daily basis.

Meet Michelle. Her cancer moves on, while the congressional ‘games’ threaten her life.

Michelle Langbehn

My name is Michelle and while the government is shut down, my cancer continues.

When the government closed late Monday night, the National Institutes of Health (NIH) was set to review my medical files to possibly be entered into a clinical trial for a new medication that could save my life. I’ve already been through nine months of chemotherapy, two cycles of radiation, a spinal fusion and several tumor removal surgeries and all of these procedures are taking a toll on my body. I have sarcoma which is a rare form of cancer. I need another form of treatment and the drug in the NIH trial I’m being considered for is it.

This isn’t just about me. Every week, about 200 new patients — including sick children — begin NIH clinical trials. Now we’re being told that we have to wait until the government re-opens to start our trials. The NIH has said that six different trials could have been started in the first week of the shutdown alone. About 75% of NIH’s employees — thousands of people — have been furloughed because of the shutdown. It’s not even just about us. What doctors learn from our medical trials could help thousands more in the future — even you or a loved one. Even if I’m not found eligible for the specific NIH trial I am being considered for, the only way that I will be able to acquire this drug will be to go through programs administered by the FDA or the National Cancer Institute (part of NIH) — both of which are also impacted by the shutdown.

I’m furious that Congress has chosen to shut down the government and leave so many of us behind. This is not just about the debt ceiling or national parks. For me, the shutdown means that Congress is denying me potentially life-saving treatment. I speak for everyone battling cancer when I say we don’t have time to wait.

The government shutdown is affecting so many of us across the country in a very personal way. For me, its affecting my fight for my life. I’ve had enough and it’s time to get NIH — and our country — moving again. It’s time to stop the government shutdown. Please join me in asking your member of Congress to stop the government shutdown and get back to functioning again.

In the meantime, I watch heated debate amongst women who have terminal cancer. These women debate the different postures of Obamacare vs the Affordable Care Act – they are one and the same but you would never know that from the strident tone. The neutral folks just proceed to understand how it will affect them and report back with pleasure, “My monthly rate just went down $300 a month!” $300 seems the reduction I most hear. (And if our household sees that, it will mean a lot! But the Oregon exchange is having some technical challenges.)

Maybe we can all agree that a 90% reduction of cancer is progress and that a 90% reduction in government is shoddy.

After 12 full days on the road this September, I am quite happy to be home as an early Fall storm gusts outside. The travels were bookended by two appointments at UPenn. My second and final apheresis pumped out then returned a full 15 liters of blood through the jugular vein in the neck.

Aphereis Blood Necklace!

A Dendritic Cell

This process allowed extraction of my now theoretically educated-via-vaccines dendritic cells. I did well but had a lot of vertigo over the next week as my body recovered from such dense draining. The dendritic cells were hurried off to the lab for storage until I enter the Phase Two section of this trial.

And I hurried off to vacation. First stop my brother’s rural home in upstate NY in the small town of Freeville outside of Ithaca. There I got to catch up with family, enjoy some stunning weather and a few kangaroos and emus that are part of my brother’s ever creative interests.

Bro & Kangaroo

After that lovely time, I was dropped off at a retreat site in the Adirondacks. We were greeted with the edict to ‘turn off your cell phones’ as we were now in a place of contained and sustained calm to allow the artists in residence to complete their projects.

Mike and I were honored to get a short stay with the fourteen others who were there for a month. Projects ranged from fictionalized looks at current day struggles in Zimbabwe and of veterans, to documentary films on things the public needs much more information on. Artists were operating in 4 different studios. A composer was winnowing down and then rebuilding an opera capturing the true story of a 13-year-old Tibetan nun made prisoner after protesting for her countries liberation. This project particularly moved me for the depth of her trials, her happy current life and the reminder that suffering can be just fine. Several community organizers were a delightful addition not only to our own project but also to the fun as between us we had many shared connections to visit about.

In our week there formal readings and presentations from six participants took place. Shared meals, time on the dock and walks allowed ample time for stimulating conversation about the work of all participants.

I opted in to the morning tai chi and quite wish I could still pop out of bed and meet on the dock for the next round of cloud hands.

We feared visiting too early for the turning of leaves but the Adirondacks border Canada and had had plenty of cold to start the process – vivid reds, yellows and the full array of oranges, greens and browns unfurled a bit more each day. Breathtaking views in all directions. We arrived to the sound of a loon and the haunting cry stayed a constant for our time there.

Our departure was rude. We left at 4 am with a seven-hour drive down to Philly courtesy of my sister-in-law. Immediately, it was the chaos of getting the right tests in the right order. Despite being determined for the labs to be complete in one poke, I had to endure a second needle to the chest with seven more vials to fill. Grrr. Cat scans are never pleasant and UPenn requires the yucky double contrast for maximum imaging. Done, we had the official end-of-study (not really) visit with my charming doctor. Lacking test results we speculated on the various options, projecting that I would be tracked into the maintenance program allowing me to use up my remaining doses of vaccine (waste not!) but at a more leisurely travel pace of chemo then vaccines once a month versus every 2 ½ weeks. The 10 cross-country treks since this started in April of 2013 have been very hard on my quite run down body. On the other hand, this trial seems to be extending my life.

The Philly Chronicles – Trek 6 (out of 10 mandated to complete the first phase of treatment – 5 for actual treatment. Clinical trials are not easy work.)

People often tell me they pray for me. I figure that is good because any pull with any gods can’t hurt my situation. I, myself, am fairly nebulous in my belief system. Raised an atheist, it always seemed hard to develop an otherworld view that included throned figures in the clouds. On the other hand, I have never seen the value in discrediting options. If it ends up there is an actual heaven and hell, I am quite sure where I want to go. Wouldn’t it be lovely to be surprised with Elysian Fields showered in sunlight or a new home amongst such billowing clouds?

A recent study revealed people who prayed for others benefited themselves, a nice outcome, albeit less for the person prayed for. In my agnostic way – open to everything, rejecting little – when folks offer to pray for me, I thank them sincerely.

On the plane this last trek my seat companion was a former seminarian. He introduced himself with handshakes to both seatmates, he helped out every distressed passenger within reach and when he realized my sorry plight he offered to pray for me and I said, “how nice.” I was not ready for what came next. Glasses removed, hands held out palms up, with the voice of an almost priest he intoned a most respectful prayer for my best outcomes. It felt a bit like Reiki. I loved the caring but was quite conscious of the odd scene. (An almost priest’s voice is trained to carry and a plane is rather small.)

And so I started this trip prayed over, a quality way to deplane to the “extreme heat emergency” that gripped the Philadelphia area. The nighttime lows were projected at 82 degrees. The daytime highs with humidity were in the low 100s. Philadelphia is not a green city. Parks are few and trees scattered about creating a slight canopy. It is a city of concrete.

The heat emergency cramped my style emotionally and actually. I have never tolerated humidity well. With an excessively fair constitution I have learned to dodge sun from an early age. I always mean to buy a parasol (wherever do you get them?) but an umbrella works just fine when I have no choice but to walk in the heat of the day. And so I marched around Philadelphia with the exception of one late afternoon commute where I hopped a bus for an air-conditioned ride home.

The treatments themselves roll along, the less thought about the better. The chemo leaves more nausea then I am used to and the big needles to the groin lymph nodes well, really, could they ever be pleasant. This is just what I do when in Philly.

I am now over the half way mark – two more treatments at both ends of August, and then two close out visits in September mark the formal end of Phase One but not of Penn treatments. What comes next was a topic of conversation with the staff there this visit. I would presumably go into either maintenance therapy once a month until the vaccine material runs out in a year or Phase Two, which is a little more dramatic then I had understood. Phase Two kicks offwith three days of back-to-back chemo, then two days of shots, then a transfusion of my jacked up t-cells extracted during my second Apherisis scheduled for September 16th, 2013. I would then resume the every 2 ½ week travel cycle for an unknown period of time. Currently, entry to Phase Two is by waiting list and triaged need, as they are at capacity. I find out in late September, post a day of testing, which route is seen as best for me. If I go the maintenance route, when and if I recur, I automatically start Phase Two procedures.

Oregon Bliss

Since returning home to Oregon’s lovely summer temperatures with no humidity, I have watched Philadelphia mellow out with nighttime lows dipping to 61. I have not had great travel luck. I should focus on the big things (please cancer, go away!) but honestly the small things matter, too – flight delays and egregious weather. If you cast a prayer my way perhaps you can take the big and the small into account. I continue to use my favorite prayer, the serenity prayer, to remind myself to let go.

A provocative, eye-opening history of the war on cancer, The Truth in Small Doses asks why we are losing this essential fight and charts a path forward.

OVER THE PAST HALF CENTURY, deaths from heart disease, stroke, and so many other killers have fallen dramatically. But cancer continues to kill with abandon. In 2013, despite a four-decade “war” against the disease that has cost hundreds of billions of dollars, more than 1.6 million Americans will be diagnosed with cancer and nearly six hundred thousand will die from it.

A decade ago, Clifton Leaf, a celebrated journalist and a cancer survivor himself, began to investigate why we had made such limited progress fighting this terrifying disease.

Timed to the book’s release he authored an opinion piece as the lead article in the July 14, 2013 New York Time’s esteemed Sunday Review section entitled, Do Clinical Trials Work?

I skimmed the lengthy piece so I won’t pretend any quality summation of his perspective but I do think he captures the moment we are in. The egregious cost of bringing any new treatment to market ($12 billion by one estimate) and the sobering failure rate of 95% of tested drugs not gaining approval, encourages drug companies to market each drug as ‘one size fits all’ cures. This correlates poorly with the huge advancement of these times – the realization of just how unique each person’s disease is and that personalized treatment is the way to go. Neither cancer treatment nor the drugs can be one-sized fits all.

Avistan is a great example of a drug marketed at great cost as a life-extender for many, many cancers. The drug costs a lot – so much that some countries like Britain have rejected its use multiple times because of the cost. Similarly many insurance carriers wont cover the cost. Proof of its effectiveness is pretty darn weak. Partially because it is a newer drug and you need time to prove that it keeps people alive longer and partially because, well, it might not be that effective; at least in the masses. There is evidence that in a small percentage of patients (I have heard as small as 3%) it could be a truly powerful life-extender. The focus should be in finding the 3% for this drug not in expending obscene sums of money to credential it as the standard of care for all patients. The drug is probably cost effective when matched with the right patient. But at that scale it might not seem cost effective to the drug company to bring to market. (Please note: Avistan is an angiogenesis inhibitor, a drug that slows the growth of new blood vessels to cancer tumors, hopefully killing the tumors. It is a drug I have been on for over a year and resisted starting it for the nine months prior despite knowing how ‘lucky’ I was to have insurance agree to pay for it. Avistan has hard side effects – surveyed women recently rated their quality of life on the drug as lowered. I would heartily concur. It makes us ache all over and reconfigures our nose’s interiors’, literally. And some of us fear it’s possible ‘blow-back’ where it may contain the cancer short term but when the cancer does come back, it is untamable.)

I bet you are starting to see the problem. Drug companies believe they can only realize profits (and remember their upper level pay scale!) if they mass market. Researchers meanwhile are now showing the breakthroughs in micro markets.

While the article casts a distressing assessment on clinical trials as a way to advance science and identify new protocols, it doesn’t disprove their value for people like me. When you have advanced, recurrent cancer of any type, you need to be on the cutting edge of treatments and or incredibly lucky. And lucky is not what most people with advanced cancer get noted as. Clinical trials have value. They give us, the patient, a shot at shopping for a better match for our situation.

It is important that patients consider what they need and how they can get it. Many patients assume that their medical team will figure this out for them but more likely, their medical team will offer them the standard of care of the moment. This may well include clinical trail options that have recently been announced or are offered at their institution but that is a poor way to match patients with trials. I have had excellent medical teamwork throughout my cancer journey and I still would not expect them to find the best trial for me – they work hard enough managing the best standard of care options for our dicey disease progression. This feels like reality amid the pressures of delivering medical care in 2013. It is the exception for a medical team to match patients up with the best trial options. It happens but when you are facing a terminal illness, such odds might not be good enough.

Given my personality, diagnosis fast led me to become a modified expert on ovarian cancer and cancer in general. My ‘expertise’ is regularly humbled in the face of other patients who seem to bring retention and some basic understanding of science to their own inquiry. Many of us cope by understanding what is going on. I have found peer-to-peer knowledge to be accurate and very helpful. Most cancers have websites that allow endless discussions on all aspects of dealing with the disease. (And yes, drug companies tend to fund them and, while not often, you will find a certain type of post gets disappeared quite fast – but that is another story.)

The point of this post is to encourage you to read Leaf’s article and book but not to get stuck in what is wrong. You don’t need to fix it, although you should consider helping out by becoming an advocate for improved practises. But what you should really, really do is know that you and your support team (best friends, lovers, family, co-workers) need to drive finding the best treatment options for your cancer, especially after you have recurred. There are tools to make this easier.

By almost any measure, clinicaltrials.gov, the website administered by the National Institutes of Health, sets the standard for providing public access to comprehensive information from around the world about research on experimental treatments for an array of diseases and conditions. Yet, despite more than a decade of efforts to improve its functionality, simplify access to its database and synthesize its information, navigating the site can be a challenge.

That’s why a Florida doctor teamed with healthcare professionals from dozens of medical centers, research institutes and medical schools to develop MyClinicalTrialLocator. MyClinicalTrialLocator.com, a site designed to make searching for a trial easier.

Designed for patients as well as medical professionals, the site not only utilizes the government database for clinical trial information but also includes important updates from medical centers conducting the research and enables users to search for trials anywhere in the world. In addition to studies of drugs and medications, the site also details studies of medical devices, procedures and interventions, and lifestyle factors, such as nutrition, diet and exercise. Users simply enter the name of their condition, their location and the distance they are willing to travel. Listings provide a plain-language summary of the trial, including recruitment information, eligibility criteria and contact details.

The service is free, and access is open to any user, though visitors are encouraged to establish an account so that they can save their searches and receive customized email updates and automatic notifications based on their search criteria. To learn more, visit MyClinicalTrialLocator.com.

There is no recipe for staying alive with advanced, recurrent cancer – and ovarian cancer by definition tends to be advanced and recurrent. Alas. Luck seems to be the only constant in outliving the odds. My luck hasn’t seemed great of late as my first recurrence has involved a year of running through various chemos until low dose taxol brought me enough shrinkage and stability to start Phase One of a clinical trial at the University of Pennsylvania. I now travel cross the USA for treatment every two and a half weeks. Is it crazy to still feel so alive?

Why not feel alive?

I completed my fifth trek to Philly and second round of treatment this past week. Outside of the city being beastly hot, there are no riveting ups or downs to report. The thunderstorms that shut down all flights just as my plane backed onto the runway sucked but that is Mother Nature and my poor relationship with the gods of travel stepping in again. For an Oregonian, though, this new constant of daily thunderstorms most afternoons is its own form of excitement – Western Oregon averaging a mere three thunderstorms a year.

The routine is becoming just that. My sister, an emergency room doc and 18-year survivor of stage 1 ovarian cancer, travelled in to greet me. She is the big sister despite her smaller frame – 18 months my elder. Living far away with her own life of demands, our rendezvous in Philly allowed her to treat me to a vacation while holding my hand, at times literally, during treatments. As someone inclined to do it all solo, it was a lovely treat. Especially the finger to squeeze and the voice to soothe as the two vaccines to the groin searched out deeper lymph nodes to inject this time.

Vacation meant strolls and delightful meals out in Philly, the city beyond hospitals.

A sister meant no luggage to schlep. A sister meant all needs all the time were met. A sister meant no need to explain or entertain, we could just be. My prescription for nausea was filled while I stayed being infused. Lovely. Although that did mean I navigated the fire alarm alone. The alarm droned, “this is not a drill” with flashing blue lights, while failing to say what you do when it is not a drill. Everyone in the ward was tied to toxic chemicals. It is a large building. The answer seemed to be for the staff to close you in your single room. Such solitary confinement never goes over well with this gal assigned a windowless chamber. So I left, found a lounge window ledge to sit on, infusion equipment in tow, and watched the fire trucks arrive. My last treatment overlapped with the collapse of a downtown building and the 12 survivors being brought to this center. I am getting used to the secondary dramas unfolding in a large urban hospital.

My ‘vacation visit’ with my sister was over too soon. I don’t know how to survive recurrent ovarian cancer but I do know enjoying the moments probably does not hurt. Hopefully, getting into one of the most exciting clinical trials of the times will help as well. Stay tuned!

Welcome to a space dedicated to the process of livingly dying – staring at imminent mortality and yet residing in the world of the living. More and more of us are finding the words terminally ill and chronic illness co-mingle. We are living longer and better despite a dire diagnosis/prognosis. But the path is not easy.

We bounce between denial, deep despair, and sheer optimism. All the while, many of us face treatment regimes that whittle us down and a current culture in the United States unfamiliar with sitting with death and dying. These writings will be of most value for:

a. people navigating the balance of living when told you are dying

b. people pursuing creative approaches, especially those stimulating our immune systems to fight back the diseases trampling us

c. people interested in witnessing one person living each day with terminal illness.

Livingly Dying Essays, Clinical Trial & Creative Approaches, and Medical Industrial Complex Woes make up the three categories on the lower right column of the front page allowing you easy access to content that most interests you. To receive new posts click the follow button in the upper right column. I share my journey to support collective efforts to live well while dying. I am feeling my way out loud. Thank you for joining me. Comments are always welcome, in fact, they cheer on the process. If you scroll below this welcome, you will find the running narrative with most current post on top.